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Comparison Between Different Technologies That Measure Respiratory Rate

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ClinicalTrials.gov Identifier: NCT02657720
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Herzog Hospital
Information provided by (Responsible Party):
Medtronic - MITG ( Oridion )

Brief Summary:
Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases. Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients. The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.

Condition or disease Intervention/treatment Phase
Healthy Device: Radical 7 Device: Capnostream20p Device: PTAF2 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparison Between Different Technologies That Measure Respiratory Rate
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Healthy volunteers
Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and PTAF2 (flow meter)
Device: Radical 7
Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Radical 7 measures respiratory rate according to acoustic respiratory rate (RRa).

Device: Capnostream20p
Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream20p measures respiratory rate using capnography (RRetCO2).

Device: PTAF2
Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. PTAF2 measures respiratory rate using flow pressure (RRflow).
Other Name: Flowmeter




Primary Outcome Measures :
  1. The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device. [ Time Frame: six months ]
    Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: breaths per minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device was accurate will be analyzed offline.


Secondary Outcome Measures :
  1. The influence of hearing or performing noises on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device. [ Time Frame: six months ]
    Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: breaths per minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device indicated respiratory rate values will be analyzed offline.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Without Clinical diagnosis of heart disease.

Exclusion Criteria:

  • Want to be excluded
  • Breathing difficulties
  • Unabling or unwilling to follow the protocol.
  • Contact allergy to the adhesive neck sensor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657720


Locations
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Israel
Herzog Hospital
Jerusalem, Israel, 91035
Sponsors and Collaborators
Oridion
Herzog Hospital
Investigators
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Principal Investigator: Michal Eisenberg, MD Herzog Hospital

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Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT02657720     History of Changes
Other Study ID Numbers: 10141352
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Medtronic - MITG ( Oridion ):
Respiratory Conditions for Adults